Liebel-Flarsheim Company LLC
Raleigh, NC, United States · makes it, packages it and labels it
Serious problems, FDA action Last FDA inspection Apr 8, 2025. 7 inspections on record, 1 with serious problems.
NDC 67684-2001
Dotarem 376.9 mg per 1 mL injection
On the label: Guerbet LLC.
Where it's made
PCAS Finland Oy
Turku, Finland · makes the active ingredient and tests it
Problems found, fixed voluntarily Last FDA inspection Jan 10, 2024. 7 inspections on record.
Simafex
Marans, France · makes the active ingredient
Problems found, fixed voluntarily Last FDA inspection Jan 31, 2025. 5 inspections on record.
Product details
- Generic drug
- Gadolinium Cation (3+): see every company that makes it
- Form
- injection, intravenous
- Strength
- 376.9 mg per 1 mL
- Approval
- NDA NDA204781
- On the market since
- Mar 20, 2013
- Package NDCs
67684-2001-067684-2001-167684-2001-267684-2001-3- Official label
- DailyMed (National Library of Medicine), updated Mar 14, 2025
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